Progress update: Mandatory reporting of adverse events by healthcare facilities

Mandatory reporting of medical device adverse events by healthcare facilities to the TGA has now commenced, with a period of voluntary reporting in place from March 2025 until 20 March 2026. This period is intended to allow time for facilities to build their reporting capability.

From 21 March 2026, reporting by healthcare facilities will become mandatory.

Reporting from healthcare facilities will enhance the quality and safety of medical devices in Australia. It improves the TGA’s ability to monitor the safety and performance of therapeutic goods and to take faster action when an issue arises.

In March 2023, the Therapeutic Goods Act was amended to require all Australian public, private and day hospitals to report medical device related adverse events to the TGA. This change is supported by amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, which came into effect in March 2025 and outline the reporting requirements. The chief executive officer (however described) of a healthcare facility holds this reporting responsibility.

For details on reporting requirements and how to report please visit Report an adverse event for medical devices - Mandatory reporting of medical device adverse events by healthcare facilities.

An Implementation Guide is also available at: Reporting of medical device adverse events by healthcare facilities.

Previous consultations

Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia.

Responses to the Discussion Paper, where consent was provided, are published on the TGA Consultation hub.

More information

• Reporting of medical device adverse events by healthcare facilities
• Mandatory reporting of medical device adverse events by healthcare facilities
• Medical devices reforms.